OncoMatch/Clinical Trials/NCT07428044
A Study of Trastuzumab Deruxtecan in People With Non-Small Cell Lung Cancer
Is NCT07428044 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Trastuzumab Deruxtecan for non-small cell lung cancer.
Treatment: Trastuzumab Deruxtecan — The purpose of this study is to find out how many people with HER2-amplified or HER2-mutated non-small cell lung cancer (NSCLC) experience a decrease in tumor viability when they receive trastuzumab deruxtecan before routine surgery to remove tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) activating mutation
Molecular testing results ... showing presence of a mutation ... of HER2. (See Appendix C for a list of known activating HER2 mutations in NSCLC. This is not intended to be a comprehensive list. The presence of any activating HER2 mutation is suitable.)
Required: HER2 (ERBB2) amplification (≥ 4 copies) (≥ 4 copies)
Molecular testing results ... showing presence of ... amplification (defined as ≥ 4 copies) of HER2
Disease stage
Required: Stage II, IIIA, SELECTED IIIB, T3N2, T4 (BY SIZE CRITERIA, NOT BY MEDIASTINAL INVASION) (AJCC 8th edition)
Excluded: Stage T4 BY VIRTUE OF MEDIASTINAL ORGAN INVASION, IIIB BY VIRTUE OF N3 DISEASE
Stage II, IIIA, or selected IIIB, including T3N2 or T4 (by size criteria, not by mediastinal invasion), NSCLC (on the basis of the 8th edition of the AJCC NSCLC staging system)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Any previous therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 3 years
Cannot have received: targeted therapy
Any previous therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 3 years
Cannot have received: immunotherapy
Any previous therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 3 years
Cannot have received: radiotherapy
Any previous therapy for lung cancer, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy, within 3 years
Lab requirements
Blood counts
Absolute neutrophil count ≥1500/uL; Platelet count ≥100,000/uL; Hemoglobin ≥9.0 g/dL; International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤1.5 × ULN; Serum albumin ≥2.5 g/dL
Kidney function
Creatinine clearance ≥30 mL/min (as calculated using the Cockcroft-Gault equation)
Liver function
AST and ALT ≤3 × ULN; Serum bilirubin ≤1.5 × ULN (up to 3 × ULN for patients with Gilbert syndrome)
Cardiac function
Echocardiogram demonstrating left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment
Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 14 days before the first dose of study treatment: ... Echocardiogram demonstrating left ventricular ejection fraction (LVEF) ≥50% within 28 days before enrollment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Michigan (Data Collection Only) · Ann Arbor, Michigan
- Mayo Clinic (Data Collection Only) · Rochester, Minnesota
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) · Montvale, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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